Outsourcing in Clinical Trials East Coast 2017 King of Prussia, PA, May

Transcription

1 Outsourcing in Clinical Trials East Coast 2017 King of Prussia, PA, May Outsourcing in Clinical Trials East Coast brings together the clinical operations and outsourcing community from pharma, biotech and medical device companies from Pennsylvania, New Jersey, New York and beyond to discuss the latest challenges in clinical operations and outsourcing. Speakers include: Mitchell Katz, Head of Clinical Research & Drug Safety Operations, Purdue Pharma Ken Getz, Director, Sponsored Research Programs, Tufts CSDD Faye O Brien, Outsourcing Programme Director, Global Medicines Development, AstraZeneca Bari Kowal, Head of Clinical Trial Management, Regeneron Pharmaceuticals Richard Robinson, Director, Clinical Operations Lead, Pfizer Susan Lubin, Director, Clinical Pharmacology Medical & Operations Group, Bristol-Myers Squibb Frank Leu, Chief Executive Officer, Novapeutics Sameer Tandon, Head of Strategic Alliances, Novartis Ratan Ratnesh, Director, Clinical Outsourcing, Otsuka Stuart Halasz, Associate Director, Clinical Quality Management, Merck Charlotte French, Senior Director, Service Provider Management, EMD Serono Debora Araujo, Associate Director, Clinical Contracting Services, Boehringer Ingelheim Michele Stonier, CRO Infrastructure Lead, Bristol-Myers Squibb Rick O Hara, Associate Director, Project Management and Business Operations, Endo Michael Snyder, Director, Clinical Operations, ContraVir Pharmaceuticals Rosalie Filling, Senior Director, Head of Clinical Operations, Lupin Pharmaceuticals Beth A. Soffer, Senior Director, Quality Preformance & Risk Management, Pfizer Inc. Terrence Tormey, Vice Chairman, Prevention Pharmaceuticals Carrie Lewis, Associate Director, Clinical Operations, Lupin Inc. Craig Coffman, Executive Director, Clinical Business Operations & Outsourcing, Nektar Therapeutics Evan Tzanis, Senior Vice President Clinical Development and Clinical Operations, Paratek Pharmaceuticals Ramzey Odetalla, Sr. Director, Clinical Research, Noven Pharmaceuticals Jennifer Sheller, Executive Director, Clinical Operations, Kyowa Kirin Pharmaceutical Development Sponsors include:

2 Outsourcing in Clinical Trials 2017 Day One May Programme Day One 7:50 Registration and refreshments 8:20 Chairman s opening remarks 8:30 Opening Keynote: Developing lean models for outsourcing of clinical development to meet the demands of recent trends within the industry Exploring experiences, thoughts and lessons learned from companies that have employed lean models to identify the use of such strategies Discussing the decision paradigms that led to the need to use lean sourcing strategies Considering the nature of the models employed to investigate their benefits, challenges and key success factors Investigating key decision that need to considered to ensure successful lean outsourcing Speaker: Mitchell Katz, Head of Clinical Research & Drug Safety Operations, Purdue Pharma 9:00 Session reserved for QuintilesIMS 9:30 Panel Discussion: Exploring how sponsors can use KPIs to measure quality to identify where time and resources need to be allocated to solidify the partnership Defining what is truly meant by KPIs and highlighting the differences between KPIs and metrics to ensure this language is being used correctly Emphasizing the need to simplify the KPI process to measure quality in a quantitative way to allow for comparison of vendors Considering which internal teams should be involved in developing KPIs for vendors to allow quality to be measured effectively Working transparently with vendors to develop effective and realistic KPIs whilst promoting accountability for tasks Considering the option of vendors providing KPIs to sponsors to encourage a true partnership that puts onus on both partners Evaluating how KPIs should change depending on project and vendor category and size Panellists: Faye O Brien, Outsourcing Programme Director, Global Medicines Development, AstraZeneca & Bari Kowal, Head of Clinical Trial Management, Regeneron Pharmaceuticals & Ramzey Odetalla, Sr. Director, Clinical Research, Noven Pharmaceuticals

3 10:00 Session reserved for Sponsor 10:30 Morning Refreshments & Networking Mid-Sized to Big Pharma Stream Small Company Stream 11:00 Developing oversight strategies to ensure effective management of CROs and other vendors and avoid trial delays Exploring the need to tailor your oversight strategies depending on vendor and sponsor size, past experience and location Dealing effectively with missed deliverables to ensure accountability whilst maintaining a solution oriented focus Developing well established specifications alongside pre-agreed milestones to clearly measure partnership success Considering who internally should be managing the outsourcing relationship to ensure the required resources are assigned Evaluating how best to go about portfoliolevel reporting and analytics for more effective oversight Speaker: Susan Lubin, Director, Clinical Pharmacology Medical & Operations Group, Bristol-Myers Squibb Exploring key aspects that need to be addressed as a start-up company moving from the preclinical to clinical space to make this transition as smooth as possible Highlighting differences when selecting and working with pre-clinical and clinical CROs to identify the best outsourcing model Considering how to go about launching international trials to highlight the reliance on CROs for smaller companies Prioritising resources and budgets to ensure costs are allocated in the most productive way Preparing in-depth trial timelines with appropriate required actions to ensure any new vendor services are identified as early as possible Appreciating the need for extra internal resources that may be required to manage additional vendors Speaker: Frank Leu, Chief Executive Officer, Novapeutics 11:30 Session reserved for SynteractHCR Session reserved for Sponsor 12:00 Panel Discussion: Considering strategies to overcome issues with staff turnover both internally and externally Evaluating what can be done to encourage CRA and investigator buy-in into your trial to reduce likelihood of turnover Encouraging the CRO to involve the sponsor in the selection of replacement staff to ensure they are the right fit for the Panel Discussion: Debating what should be considered at the start of a trial to build effective partnerships Identifying what should be included in a typical RFP to facilitate the comparison of bids Emphasizing the need for a concise but thorough Scope of Work to be provided to ensure suitable responses are received

4 trial Investigating the option of using retention bonuses as way of saving costs in the long term Assessing the option of working with consultants to avoid dealing with staff turnover on the same scale Recognizing the need for pharma leadership teams to match what is provided to employees at CROs Panellist: Richard Robinson, Director, Clinical Operations Lead, Pfizer Using the questions posed by vendors in responses as an indicator of vendor knowhow and experience Exploring key preparation aspects to consider before the Bid Defense Meeting to ensure the right partner is found for your trial Considering who should be present at the meetings to ensure a streamlined approach whilst obtaining the required input Rick O Hara, Associate Director, Project Management and Business Operations, Endo Michael Snyder, Director, Clinical Operations, ContraVir Pharmaceuticals Rosalie Filling, Sr. Director, Head of Clinical Operations, Lupin Pharmaceuticals 12:30 Session Reserved for Acurian Session Reserved for PSI 1:00 Networking Lunch 2:00 Investigating the state of feasibility assessments and strategies to improve your methodology Considering why, despite technological improvement and real-time access to date, the industry continues to be plagued by common errors and oversights Defining two distinct steps to feasibility; Medical and Operational feasibility to identify the differences between both Investing time and resources into improving feasibility assessments to meet the demands of more complex protocols Exploring different tools that can support the feasibility processes and streamline this process Speaker: Sameer Tandon, Head of Strategic Alliances, Novartis 2:30 Session reserved for INC Research Case Study: Exploring how working with large scale CROs can be the key to international trial management Ensuring you plan in due time for international trial growth in order to guide your vendor selection process Recognizing the need for an increased spend on a global CRO at the outset to avoid incurring extra costs as your trial expands Considering how best to capitalize on a vendors global reach to ensure you are getting what you paid for Overcoming any issues with being seen as a second class customer by large scale CROs Michael Snyder, Director, Clinical Operations, ContraVir Pharmaceuticals Optimizing sponsor/cro relationships to ensure the success of your clinical trials

5 Understanding key factors that drive Sponsor-CRO relationships Providing tips for negotiation Discussing financial management and reporting Reviewing several short case studies Kristen Snipes, Project Director, Rho 3:00 Establishing an end-to-end approach to business operations for clinical research to allow for more effective forecasting and budgeting Promoting the idea of business operations and outsourcing teams being under the same management to avoid any knowledge being lost Considering how best to build links between project management and business operations to improve forecasting and budgeting processes Ensuring specific plans and processes for each team when change order occurs to minimize their impact Developing plans for forecasting strategies as the trial grows to international levels or takes different avenues Speaker: Charlotte French, Senior Director, Service Provider Management, EMD Serono Building effective management strategies when working with third party vendors to secure oversight across all aspects of the trial Setting out clear expectations of any third party vendors with a full service CRO at the outset Defining metrics to clarify when sponsors should interfere to ensure quality standards to not slip Ensuring roles are accurately and transparently defined to avoid duplication of efforts and costs from multiple parties Considering the benefits of allowing CROs to centrally manage other vendors to promote the idea of a true partnership Debating whether CROs will negotiate effectively to ascertain whether they can maintain required level of costs Carrie Lewis, Associate Director, Clinical Operations, Lupin Pharmaceuticals 3:30 Afternoon Refreshments & Networking 4:00 Recognizing what can be done by all partners, staff and stakeholders to improve inspection readiness Promoting the idea of being in a constant state of preparation rather than preparing for a one-off inspection Emphasizing the need for effective TMF management; ensuring data is not only collected in the right way but also accessible when required Debating what senior management within both sponsors and CROs need to do to ensure a culture of compliance Questioning whether electronic TMF can be a solution or an obstacle in future trial management Ensuring all required staff, internally and externally, locally and globally are aware of requirements

6 and are reachable to improve response times Exploring other technological solutions to improving trial management and improving success rates during inspection Speaker: Stuart Halasz, Associate Director, Clinical Quality Management, Merck 4:30 Taking a risk-based approach using advanced analytics to oversee vendors and investigative sites- A Case Study Ensuring the health of investigative sites requires a more evolved approach in the way we deploy recourses, manage risks and quality issues, and identify trends Building the story with analytical tools ensures effective oversight of quality and performance to prevents poor outcomes Incorporating the direction of ICH E6 Revision 2 which is helping to drive the approach to ensuring quality in clinical trials Beth A. Soffer, Senior Director, Quality Performance & Risk Management, Pfizer Inc 5:00 Chairman s closing remarks and close of Day One Outsourcing in Clinical Trials 2017 Day Two 24 th May 2017 Programme Day Two 8:15 Registration and refreshments 8:50 Chairman s opening remarks 9:00 Stream A: Pharma and Biotech Considering how best to engage with all stakeholders to develop trial strategies that fit the needs to all parties and is most beneficial to patients Recognizing what different stakeholders can stand to gain from your trial to allow for a more targeted approach to engagement Evaluating how best to work with patient groups to develop patient-centric trials to improve patient retention and recruitment rates Stream B: Medical Device Evaluating best practice for identifying and qualifying suppliers discovering engaging sites that adjust and deliver beyond expectations Identifying successful sites within specific fields who accommodate to your needs working towards a common goal Assessing methods to ascertain expert medical staff to work with encouraging a smooth running of the trial Investigating multiple suppliers to identify who carries out the most suitable enrolment process for your study

7 Considering how to find sites that are looking to engage, and developing processes that simplify tasks for trial to ensure effective collaboration Highlighting the benefits of working with CROs that have their own site networks whilst being sure to not be influenced by this when developing site relationships Developing communication routes between senior level sponsor executives and sites to ensure they are aware of the specific trial and sponsor needs Qualifying site coordinators and encouraging frequent communication promoting effective project management Gabriela Gottlieb, MPH, Regulatory and Clinical Affairs Manager, Maxx Orthopedics Craig Coffman, Executive Director, Clinical Business Operations & Outsourcing, Nektar Therapeutics 9:30 Embracing Opportunity in the Asia-Pacific: Identifying and building opportunities in the world s most dynamic region. Identifying and debunking the common misconceptions that exist around conducting clinical trials in the Asia-Pacific region Examining various recruitment and retention strategies and trends in the Asia- Pacific Outlining opportunities to save time and money in specific countries and throughout the broader region Identifying and discussing opportunities (Predominance of western diseases, facilities, literacy rates, technology usage and prescribing patterns, for example) and how these will impact on clinical trials and future practice studies in the region. Dr Maria Ali, Associate Director, Medical & Regulatory Services, George Clinical Striking the balance between outsourcing and using in-house resources to improve efficiency in your trial Evaluating your internal expertise to decide which processes to outsource ensuring you make the most of in-house capabilities and continue being costeffective Addressing advantages and challenges of hybrid vs full outsourcing models identifying which is more suitable for your company Ensuring you are attracting successful suppliers who will provide clinical and regulatory experts to work with you on your device trial Uncovering a small companies perspective on which model of outsourcing is the most cost-effective method to remain within the budget restrictions Cathy Dawson, Director Clinical Affairs, Aesculap 10:00 Case Study: Developing strategies for when it all goes wrong; considering how to maintain relationships when challenges occur Recognizing what the sponsor can do as Exploring the development of combination products and recent guidelines that will influence the developmental process Identifying recent guidelines and clinical

8 soon as red flags are raised to reduce the impact of any issues Creating effective escalation strategies within the contract in case of any issues to facilitate quick solutions Re-establishing communication with vendor business development teams in case of under delivery Does the end mean the end; ensuring bridges aren t burnt in the event you need to change CROs mid-trial Learning from past lessons to highlight what must be thought about from the outset to avoid issues midway through the trial factors to consider when undergoing a trial involving combination products Addressing the different regulatory pathways available for combination products and how this impacts all aspects of product development Overcoming challenges associated with review management to ensure your product gets to market as efficiently as possible Lori-Anne Woodard, Senior Manager Quality Compliance Combination Products, Teva Pharma Evan Tzanis, Senior Vice President Clinical Development and Clinical Operations, Paratek Pharmaceuticals 10:30 Morning Refreshments & Networking 11:00 Implementing investigator site payment strategies for success in outsourced trials 11:30 Identifying opportunities before and during Clinical Trial Agreement negotiations for site payment success regardless of outsourcing model Automation, transparency and centralization for improved overall site payment experience Engaging sites early to avoid potential bottlenecks during the site payment stage Customizing the site payment approval process for improved payment cycle times Exploring the implementation of site feedback mechanisms as a way of constantly improving site payment relationships Debora Araujo, Associate Director, Clinical Contracting Services, Boehringer Ingelheim Exploring the importance of inclusion of diverse patient populations in clinical trials Comparing the advantages and regulatory requirements involved with undertaking a Registry vs IDE (Investigational Device Exemption) study Identifying the FDA-associated hurdles involved for each option ensuring the credibility of your study Addressing the pivotal nature of each study in order to optimise time-efficiency and cost-effectiveness Examining source verification documents requirements to assure GCP compliance Comparing the level of work required for IDE vs a non-ide study to decide which option is most suitable for you Uncovering the value of implementing a Registry study for medical devices and how to run it economically to successfully move through the post-market phase Steve Sisk, Director, Clinical Operations, CytoSorbents Corporation Addressing the trials and tribulations of

9 12:00 Investigating the importance of racial and ethnic balancing in clinical development Exploring reasons for under-representation of minorities Developing strategies to increase representation of minorities Analysing FDA involvement in the inclusion of diverse patient populations in clinical trials Dr. Alfonso Alanís, Chief Medical and Development Officer, Research Point Small Pharma: Building efficient, effective quality oversight & governance model Transitioning from "big" to small pharma Trial management role harmonization with risk based oversight Executive Management Oversight - Governance Model Identifying and engaging with ideal vendors / CROs for your organization -- streamlining, preferred vendor model Jennifer Sheller, Executive Director, Clinical Operations, Kyowa Kirin Pharmaceutical Development outsourcing medical device studies in smaller companies to adhere to strict timelines and budgets Hear from 2 innovative 15 minute presentations on the hurdles faced by smaller device companies and discuss possible solutions to them, followed by 25 minutes Q&A. Identifying challenges faced when working with vendors who lack experience working with start-ups to establish expectations and guidelines Highlighting the importance of economic and timeline constraints compared to larger companies to guarantee the site understands the study objectives Addressing enrolment challenges faced by smaller companies to ensure you recruit the right patient population which in turn reflects the validity of the study Emphasizing the importance of CROs being flexible with their protocol to fit with the companies restrictions and work together effectively Presentation 1: Baruch Ben-Dor, Chief Executive Officer, InfraScan Presentation 2: Helen Hahn, Director Medical Affairs, Alliqua Panellists: Baruch Ben-Dor, Chief Executive Officer, InfraScan; Cathy Dawson, Director Clinical Affairs, Aesculap; Helen Hahn, Director Medical Affairs, Alliqua; Heidi Goldsmith, Director of Clinical Studies, Aspire Bariatrics 12:30 Networking Lunch 1.45 A Rational Approach to Managing Sponsor Vendor Relationships Outsourcing relationships are often driven by irrational management approaches such as personality compatibility or non-scientific metrics. In this presentation, I will describe a scientific Defining strategies such as remote monitoring to ensure the correct level of oversight required occurs throughout the study Identifying the importance of partnerships between vendors and medical device

10 approach to managing outsourcing relationships. At the end of this session, attendees will be able to: describe the shortcomings in current approaches to clinical trial performance measurement, follow the scientific methods for creating their own performance measures that are valid and reliable in their specific context, - use these scientific measures to rationally guide sponsor vendor relationships Michael Howley, Associate Clinical Professor, Drexel University companies to ensure all stakeholders are working towards a common goal Promoting face-to-face meetings with the vendor before the trial begins to delegate responsibilities and identify risks in advance Defining regular points of contact between CRO and site during the trial to keep to the timeline and confirming the project plan aligns with stakeholders Examining the idea of remote monitoring to ensure the trial and budgets are managed accordingly Dana Keane, Clinical Affairs Director, Optos 2.15 The Changing Outsourcing Landscape and its Impact on Drug Development Operating Conditions Reviewing new data characterizing the structure of the market for outsourced services Highlighting major trends and M&A activity driving consolidation and operating change Discussing strategies anticipating landscape change to drive development performance Speaker: Ken Getz, Director, Sponsored Research Programs, Tufts CSDD Addressing the use and collection of CGM (Continued Glucose Monitoring) data in a clinical trial and also other med devices Addressing all stages from protocol design to data analytics to apply the device to a trial and maintain it throughout End point consideration- addressing what to do with data and understanding what you want to get out of the trial to ensure success Establishing the steps involved with trial initiation and maintenance Identifying methods of data analysis and normalisation to easily assess the data collected from the CGM device Robert Sala, Director, Dexcom 3:00 Afternoon Refreshments & Networking 3:30 Speaker Hosted s Each roundtable session lasts for 40 minutes, and delegates may attend up to 2 roundtables Biopharma 1 Developing best practices for outsourcing in rare disease trials

11 Medical Device 1 Biopharma 2 Medical Device 2 Biopharma 3 Biopharma 4 Developing a comprehensive approach to CRO selection to reduce time to study start-up Facilitator: Duane R Dey, Director Clinical Affairs, Ortho Clinical Diagnostics reserved for George Clinical Discussing how to get a balance between outsourcing and utilizing in-house resources to maximize efficiency in your device trial Helen Hahn, Director Medical Affairs, Alliqua Investigating the true value of Risk Based Monitoring Developing effective infrastructures for effective management of CROs Facilitator: Michele Stonier, CRO Infrastructure Lead, Bristol-Myers Squibb 4:50 Chair s summation and close of conference